Headline

Regulatory affairs-(US Market) || CMC || Post Approval ||

About

Detail-oriented and motivated Regulatory Affairs professional currently working as a Jr. Regulatory Officer at Macleods Pharmaceuticals Limited, specializing in regulatory submissions for the US market. I have hands-on experience in compiling, reviewing, and submitting regulatory submissions, as well as preparing accurate and timely responses to FDA queries, including Complete Response Letters (CRLs), Information Requests (IRs), and Deficiency Response Letters (DRLs). My responsibilities include managing post-approval changes related to CMC and Labeling requirements—such as CBE-0, CBE-30, PAS and Annual Reports—while ensuring full compliance with FDA regulations. I am adept at supporting end-to-end regulatory activities, including electronic submission through the FDA ESG NextGen portal. With a strong background in eCTD compilation and lifecycle management, I collaborate effectively with cross-functional teams to drive compliance, accuracy, and efficiency in all regulatory filings. Keen to further advance my expertise in global regulatory strategy, CMC, labeling, and dossier management, I am passionate about contributing to high-quality, compliant drug product submissions that improve patient access and health outcomes.

Location

Thane

Work experience

Regulatory Affairs Jr Officer at MACLEODS PHARMACEUTICALS LTD., Jan 2025 - Present · 1 yr 6 mos

Regulatory Affairs Associate at MACLEODS PHARMACEUTICALS LTD., Jul 2024 - Jan 2025 · 7 mos, On-site

Regulatory Affairs Intern at MACLEODS PHARMACEUTICALS LTD., Jan 2024 - Jul 2024 · 7 mos, Mumbai

Postgraduate Student at SHOBHABEN PRATAPBHAI PATEL SCHOOL OF PHARMACY & TECHNOLOGY MANAGEMENT, Oct 2022 - Aug 2024 · 1 yr 11 mos, Mumbai

Education

M Pharmacy, Regulatory Affairs, SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

Bachelor of Pharmacy - BPharm, Pharmacy, University of Mumbai